The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.
The decision to perform a percutaneous coronary intervention (PCI) is usually based on angiographic results alone. Angiography can be used for the visual evaluation of the inner diameter of a vessel. Visual evaluation is limited by inter-individual variability. Fractional flow reserve provides a functional evaluation, by measuring the pressure decline caused by a vessel narrowing. The original studies validating the use of FFR were conducted with only one device (St-Jude Medical®). Recently, new FFR devices have been commercialized but have not yet been compared.
Study Type
OBSERVATIONAL
Enrollment
30
Comparison of different devices measuring fractional flow reserve
CAEN University Hospital
Caen, France
Simultaneous FFR measure SJM and ACIST
Correlation between simultaneous measures with St Jude medical FFR device and ACIST device
Time frame: Immediately
Simultaneous FFR measure Boston Scientific and ACIST
Correlation between simultaneous measures with BOSTON Scientific FFR device and ACIST device
Time frame: Immediately
Simultaneous FFR measure Boston Scientific and SJM
Correlation between simultaneous measures with BOSTON Scientific FFR device and St Jude Medical device
Time frame: Immediately
FFR SJM or Boston alone versus simultaneous with ACIST
Correlation between SJM and Boston Scientific FFR measurements alone and simultaneous measure with ACIST
Time frame: Immediately
Clinical concordance
Concordance between FFR values \>0.80 or \<=0.80
Time frame: Immediately
Drift of the signal
variation between the initial measure in the aorta (equalization) and final measure
Time frame: immediately
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